{
  "node_id": "us-fda-21-cfr-312-ind-application-investigational-new-drug",
  "title": "US FDA 21 CFR Part 312 - Investigational New Drug (IND) Application Requirements",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2024-03-01",
  "bluf": "FDA regulations at 21 CFR Part 312 govern the Investigational New Drug (IND) application process required before conducting clinical studies of unapproved drugs or approved drugs for new indications in the US…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
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  "crosswalks": {
    "_available_keys": [
      "industry_mapping",
      "use_cases",
      "related_standards",
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    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "fda-21-cfr-210-211-current-good-manufacturing-practice",
    "us-fda-21-cfr-part-11-electronic-records"
  ],
  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 18,
  "citation_preview": [
    {
      "title": "21 CFR Part 312 - Investigational New Drug Application",
      "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312",
      "section": "312.20 (requirement), 312.23 (content), 312.32 (safety reports), 312.33 (annual reports)"
    },
    {
      "title": "FDA Guidance for Industry: IND Applications for Clinical Investigations",
      "url": "https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application",
      "section": "IND content and procedural requirements"
    }
  ]
}